CurrentmhnPolicy CP.MP.249

Allogeneic Hematopoietic Progenitor Cell Therapy

Medical necessity criteria for coverage of Omisirge (omidubicel) and RegeneCyte (HPC cord blood) for non‑Medicare health plans affiliated with Centene; indicates which diagnoses, age ranges, and transplant settings are covered.

Policy Summary

Payermhn

PolicyAllogeneic Hematopoietic Progenitor Cell Therapy

Policy CodePolicy CP.MP.249

Change TypeAdded and revised coverage criteria

Effective Date

Next Review Date

Key ActionObtain prior authorization and provide documentation of patient age, diagnosis, transplant type, conditioning regimen, and that the request is for the single specified administration.

SourceLink

POLICY UPDATE CHANGES

Added medically necessary criteria for RegeneCyte (HPC Cord Blood) as Criteria II.

Updated Criteria I to include severe aplastic anemia as a medically necessary indication for Omisirge.

Clarified that policy I applies to non‑Medicare health plans and directs Medicare criteria to a separate Medicare policy (MC.CP.MP.249).

2FDA‑approved allogeneic HPC products covered

≥12 yrsOmisirge age threshold (hematologic malignancies)

≥6 yrsOmisirge age threshold (severe aplastic anemia)

one administrationOmisirge dosing context

Coverage Criteria

Criteria I — Omisirge (omidubicel)

Covered when ALL of the following are met for Omisirge (Criterion I):

Omisirge coverage — indication-specific branches

Omisirge for hematologic malignancies: Member is ≥ 12 years of age AND planned for an umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection AND request is for one administration post-myeloablative conditioning.
Omisirge for severe aplastic anemia: Member is ≥ 6 years of age AND request is for one administration following reduced intensity conditioning.

Operational note: Prior authorization is required and documentation should support patient age, diagnosis, planned transplant type, conditioning regimen type, and that the request is for the single specified administration in the post‑conditioning setting.

Policy Summary

Payermhn

PolicyAllogeneic Hematopoietic Progenitor Cell Therapy

Policy CodePolicy CP.MP.249

Change TypeAdded and revised coverage criteria

Effective Date

Next Review Date

Key ActionObtain prior authorization and provide documentation of patient age, diagnosis, transplant type, conditioning regimen, and that the request is for the single specified administration.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Criteria II — RegeneCyte (HPC Cord Blood)

Covered when ALL of the following are met for RegeneCyte (Criterion II):

RegeneCyte coverage: Member is planned for an unrelated donor hematopoietic progenitor cell transplantation procedure AND an appropriate preparative regimen for hematopoietic and immunologic reconstitution will be used in conjunction with the transplantation procedure AND member has a disorder affecting the hematopoietic system that is inherited, acquired, or a result from myeloablative treatment.

Operational note: Prior authorization is required and documentation should support planned transplant type and use of an appropriate preparative regimen for hematopoietic and immunologic reconstitution.

Covered Preparative Regimens

Regimen / Context	Specification (age, conditioning, administration)	Coverage stance
Myeloablative conditioning for Omisirge in hematologic malignancies	Member is ≥ 12 years of age; planned for umbilical cord blood transplantation following myeloablative conditioning to reduce time to neutrophil recovery and infections; request is for one administration post‑myeloablative conditioning.	Covered
Reduced‑intensity conditioning for Omisirge in severe aplastic anemia	Member is ≥ 6 years of age; request is for one administration following reduced intensity conditioning.	Covered
Appropriate preparative regimens for RegeneCyte (HPC cord blood)	Member is planned for an unrelated donor hematopoietic progenitor cell transplantation procedure; an appropriate preparative regimen for hematopoietic and immunologic reconstitution will be used in conjunction with the transplantation procedure; indication is a disorder affecting the hematopoietic system that is inherited, acquired, or resulting from myeloablative treatment.	Covered

Provider Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests will be reviewed against policy medical necessity criteria and clinical documentation must be provided to support the indication and planned transplant regimen.

Prior authorization required and reviewed against policy criteria
Submit request prior to procedure/administration

Step Therapy

No step therapy requirements are specified in this policy.

Documentation Required

Required Documentation

Provide complete clinical documentation to support medical necessity, including patient age, specific diagnosis, transplant plan and donor type, preparative (conditioning) regimen, and timing of the requested single administration relative to conditioning.

Member age (date of birth) and age at time of transplantation
Primary diagnosis (e.g., hematologic malignancy or severe aplastic anemia) with supporting clinical notes and testing
Planned transplantation type (umbilical cord blood transplantation or unrelated donor hematopoietic progenitor cell transplantation)
Planned conditioning regimen intensity (myeloablative vs reduced intensity) and schedule
Planned timing of requested product administration (e.g., single administration post-myeloablative conditioning or following reduced intensity conditioning)
Transplant plan documentation (treatment plan, transplant center notes)

Denial Risk

Denial Triggers

Requests lacking required indications or documentation are likely to be denied. Denials may be issued when policy criteria are not met.

Age below policy thresholds (hematologic malignancy: < 12 years; severe aplastic anemia: < 6 years)
Diagnosis not specified or not one of the covered indications (e.g., indication other than hematologic malignancy or severe aplastic anemia or not a disorder affecting the hematopoietic system when required)
Planned transplant type not consistent with policy (e.g., not an umbilical cord blood transplantation when myeloablative indication specified, or not an unrelated donor hematopoietic progenitor cell transplantation when RegeneCyte indication specified)
Conditioning regimen intensity not matching the criterion (e.g., myeloablative required for hematologic malignancy indication; reduced intensity required for severe aplastic anemia indication)
Request for more than one administration or administration timing inconsistent with policy (policy specifies one administration post-conditioning)
Insufficient clinical detail to confirm transplant plan, preparative regimen, or timing

Definitions

myeloablative conditioning (MAC) — definitions and related preparative regimen terms

Definition of myeloablative conditioning (MAC)A regimen (single agent or combination) anticipated to destroy hematopoietic cells in the bone marrow; causes extensive pancytopenia within 1–3 weeks that is typically irreversible.

MAC clinical intentUsed to ablate marrow to eradicate disease prior to allogeneic hematopoietic progenitor cell transplantation, facilitating donor engraftment.

Reduced intensity / non‑MAC regimensLower‑intensity preparative regimens (reduced intensity conditioning) are specified for Omisirge use in severe aplastic anemia (approved for patients ≥6 years following reduced intensity conditioning).

Preparative regimen requirement for RegeneCyteRegeneCyte is approved for use in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution (regimen types not standardized in COBLT study).

Background

Allogeneic hematopoietic progenitor cell transplantation replaces a patient’s hematopoietic system by infusing donor stem/progenitor cells after a preparative conditioning regimen. Myeloablative conditioning is used to eradicate disease and typically causes prolonged pancytopenia, creating the need for reliable and timely hematopoietic reconstitution. Omisirge (omidubicel), a nicotinamide‑modified cord blood–derived product, and RegeneCyte (HPC cord blood) are FDA‑approved allogeneic products intended to accelerate neutrophil and broader hematopoietic recovery in the setting of planned umbilical cord blood or unrelated donor transplantation when used with an appropriate preparative regimen. These therapies are intended for use as part of the transplant procedure to achieve hematopoietic and immunologic reconstitution rather than as standalone treatments.

J3590	Unclassified biologics.
C9399	Unclassified drugs or biologicals

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